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A Phase II Study of Prophylactic Radiation Therapy for the Prevention of Hemoptysis in Advanced Non Small Cell Lung Cancer in Combination With Bevacizumab, Paclitaxel, and Carboplatin in Patients at High Risk for Bevacizumab-Associated Hemoptysis

Trial Information

A Phase II Study of Prophylactic Radiation Therapy for the Prevention of Hemoptysis in Advanced Non Small Cell Lung Cancer in Combination With Bevacizumab, Paclitaxel, and Carboplatin in Patients at High Risk for Bevacizumab-Associated Hemoptysis

PRIMARY OBJECTIVES:

I. Evaluate the safety of prophylactic chest radiotherapy, bevacizumab, paclitaxel, and carboplatin in patients with unresectable stage IIIB or IV non-small cell lung cancer at high risk for bevacizumab-associated hemoptysis.

SECONDARY OBJECTIVES:

I. Assess progression-free survival of patients treated with this regimen. II. Assess the rate of objective response, overall survival, time to response, and response duration in irradiated lesions and non-irradiated lesions in these patients.

OUTLINE: This is an open-label, pilot, multicenter study. Patients are assigned sequentially to 1 of 2 treatment strata.

Stratum I: Patients undergo prophylactic radiotherapy on days 1-5 and 8-12. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 15. Patients also receive paclitaxel IV over 3 hours or carboplatin IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 36 (course 2).

Stratum II: Patients undergo prophylactic radiotherapy and receive paclitaxel and carboplatin as in stratum I. Patients also receive bevacizumab IV over 30-90 minutes on day 15 (course 1). In both strata, treatment with paclitaxel, carboplatin, and bevacizumab repeats every 21 days for 5-6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease may continue to receive single-agent bevacizumab every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 12 months.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.

- Primary tumor of any T stage within or touching the zone of the proximal bronchial tree

- Zone is defined as a 3-dimensional volume with a perimeter of 2 cm in each direction around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)

- Any disease within this volume must not invade blood vessels determined by a contrast-enhanced CT scan evaluation of the entire thorax with thin slices (≤ 5 mm) through the area of central tumor bulk (i.e., no evidence of vessel invasion radiological evaluation)

- Stage IIIB (with malignant pleural effusion) or stage IV disease

- Patients with stage IIIB NSCLC without an effusion are eligible if they are not candidates for combined modality therapy with curative intent (i.e., radical chemoradiotherapy)

- At high risk for bevacizumab-associated hemoptysis

- Hemoptysis estimated as between 2.5 mL and 10 mL (largest volume of single episode of hemoptysis) in the past 2 months

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days

- No significant traumatic injury within the past 28 days

- No history of known allergy or reaction attributed to compounds of similar chemical or biological composition to bevacizumab, such as Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies, Cremophor EL®, or other agents used in study treatment

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